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Clinical Operations Specialist
2 months ago
At Syneos Health, Inc., we are a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health, Inc. easier to work with, but to make us easier to work for.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Why Syneos Health, Inc.We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
Job ResponsibilitiesKey Responsibilities:
- Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.
- Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures, and relevant guidelines.
- Create and assist with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
- Prepare and maintain site manuals, reference tools, and other documents.
- Maintain, update, and input clinical tracking information into databases.
- Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
- Manage shared mailbox, process site requests, and route correspondence appropriately.
- Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials.
- Assist with coordination of team meetings, attend meetings, and prepare accurate meeting minutes and action items.
- May handle receipt, tracking, and disposition of Case Report Forms and Queries.
- Maintain overall awareness in the field of clinical research by completing all necessary and assigned training.
Requirements:
- High School diploma or equivalent.
- Good communication and interpersonal skills.
- Ability to embrace new technologies.
- Minimal travel up to 25% may be required.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
